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Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

Primary Purpose

Secondary Hyperparathyroidism, Dialysis

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Paricalcitol injection
Paricalcitol capsules
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Dialysis, Hyperparathyroidism, Zemplar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL)
  • Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment
  • Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator
  • Patients providing their signed informed consent to participate in the trial

Exclusion Criteria:

  • Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml)
  • Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x phosphorus >= 70
  • Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
  • Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
  • Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum
  • Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D

Sites / Locations

  • Site Ref # / Investigator 19391
  • Site Ref # / Investigator 19389
  • Site Ref # / Investigator 19390
  • Site Ref # / Investigator 19393
  • Site Ref # / Investigator 19395
  • Site Ref # / Investigator 19392
  • Site Ref # / Investigator 19397
  • Site Ref # / Investigator 19396
  • Site Ref # / Investigator 19394
  • Site Ref # / Investigator 19399
  • Site Ref # / Investigator 19398
  • Site Ref # / Investigator 19388

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paricalcitol injection

Paricalcitol capsules

Arm Description

ABT-358 Zemplar

ABT-358 Zemplar

Outcomes

Primary Outcome Measures

Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level
Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.

Secondary Outcome Measures

Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)
Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.
Proportion of Subjects Who Achieve an iPTH <300 pg/mL
Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.
Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level
Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.
Duration of Response to Treatment
Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.
Health-related Quality of Life With Paricalcitol Injection or Oral Treatment
Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.

Full Information

First Posted
September 28, 2007
Last Updated
September 16, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00537979
Brief Title
Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
Official Title
Prospective, Non-randomized, Multicenter Study to Assess the Efficacy and Safety of Oral or Intravenous Paricalcitol Administered Over 6 Months to Patients With Secondary Hyperparathyroidism on Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Dialysis
Keywords
Dialysis, Hyperparathyroidism, Zemplar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol injection
Arm Type
Active Comparator
Arm Description
ABT-358 Zemplar
Arm Title
Paricalcitol capsules
Arm Type
Active Comparator
Arm Description
ABT-358 Zemplar
Intervention Type
Drug
Intervention Name(s)
Paricalcitol injection
Other Intervention Name(s)
ABT-358, paricalcitol, Zemplar
Intervention Description
Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
Intervention Type
Drug
Intervention Name(s)
Paricalcitol capsules
Other Intervention Name(s)
ABT-358, paricalcitol, Zemplar
Intervention Description
Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
Primary Outcome Measure Information:
Title
Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level
Description
Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)
Description
Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.
Time Frame
24 Weeks
Title
Proportion of Subjects Who Achieve an iPTH <300 pg/mL
Description
Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.
Time Frame
24 weeks
Title
Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level
Description
Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.
Time Frame
24 weeks
Title
Duration of Response to Treatment
Description
Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.
Time Frame
24 weeks
Title
Health-related Quality of Life With Paricalcitol Injection or Oral Treatment
Description
Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.
Time Frame
Baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL) Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator Patients providing their signed informed consent to participate in the trial Exclusion Criteria: Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml) Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x phosphorus >= 70 Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose-Luis Cañadas, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 19391
City
Jojutla Morelos
ZIP/Postal Code
CP 62900
Country
Mexico
Facility Name
Site Ref # / Investigator 19389
City
Mexico City
ZIP/Postal Code
CP 03900
Country
Mexico
Facility Name
Site Ref # / Investigator 19390
City
Mexico City
ZIP/Postal Code
CP 14000
Country
Mexico
Facility Name
Site Ref # / Investigator 19393
City
Mexico City
ZIP/Postal Code
CP 14080
Country
Mexico
Facility Name
Site Ref # / Investigator 19395
City
Mexico City
ZIP/Postal Code
CP 16070
Country
Mexico
Facility Name
Site Ref # / Investigator 19392
City
Mexico D.F.
ZIP/Postal Code
CP 01030
Country
Mexico
Facility Name
Site Ref # / Investigator 19397
City
Mexico D.F.
ZIP/Postal Code
CP 02080
Country
Mexico
Facility Name
Site Ref # / Investigator 19396
City
Mexico D.F.
ZIP/Postal Code
CP 03650
Country
Mexico
Facility Name
Site Ref # / Investigator 19394
City
Mexico D.F.
ZIP/Postal Code
CP 14140
Country
Mexico
Facility Name
Site Ref # / Investigator 19399
City
Puebla
ZIP/Postal Code
CP 72400
Country
Mexico
Facility Name
Site Ref # / Investigator 19398
City
Zapopan
ZIP/Postal Code
CP 45116
Country
Mexico
Facility Name
Site Ref # / Investigator 19388
City
Zapopan
ZIP/Postal Code
CP 45150
Country
Mexico

12. IPD Sharing Statement

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Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

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